MRE as a Screening Tool for axSpA in IBD

Crohn Disease Clinical Trial

— ProSpA-CD  

Official title:

Magnetic Resonance Enterography as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease: A Prospective Single-center Cross-sectional Observational Study Using MRE Screening Followed by Clinical Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817983
• Other study ID #: A094864
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: August 8, 2020

Study information

• Verified date: March 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.

Description:

Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which also captures the axial skeleton and can therefore be used to screen for evidence of axial SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology clinic to assess more specifically for SpA. This will include completion of patient reported outcome measures, clinical examination, routine blood tests, HLA-B27 genotyping and a dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence of axSpA.

This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axSpA in CD cases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: August 8, 2020
• Est. primary completion date: August 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects who are willing and able to give informed consent for participation in the study.

2. Male and female subjects aged 18 years or above.

3. Diagnosed by the gastroenterology team with Crohn's disease.

4. MRE imaging since 2015 for their Crohn's disease.

Exclusion Criteria:

1. Subjects unwilling or unable to give informed consent.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Crohn Disease
• Spondylarthritis

Intervention

Diagnostic Test:
• MRE review for axSpA
Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease followed by clinical and MRI assessment

Locations

Country	Name	City	State
United Kingdom	Rheumatology Research Unit	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of MRE as a screening tool for axial spondyloarthritis in Crohn's disease		12 months
Secondary	The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the 2009 ASAS criteria for axial Spondyloarthritis.	ASAS (Assessment of Spondyloarthritis International Society)	12 months
Secondary	The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the modified New York criteria for Ankylosing spondylitis		12 months
Secondary	The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the CASPAR criteria for psoriatic arthritis	CASPAR (Classification Criteria for Psoriatic Arthritis)	12 months
Secondary	The proportion of these patients (expressed as a percentage) proceeding to non-pharmacological and pharmacological treatment of their axial Spondyloarthritis, as a surrogate measure of change in clinical care as a result of MRE screening.		12 months
Secondary	The predictive value of specific extra-articular features with a diagnosis of axial spondyloarthritis in Crohn's disease		12 months
Secondary	The predictive value of a particular site of Crohn's disease (colon, ileum etc) with a diagnosis of axial spondyloarthritis in Crohn's disease		12 months